Clinical Study to Improve Diagnosis and Treatment of Sinusitis
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Purpose
Chronic rhinosinusitis (CRS) is the most common chronic medical condition that affects Americans between 18-44 years of age. While significant advances have been made in the understanding of the molecular pathogenesis underlying many subtypes of CRS, this has not translated into widespread changes in how physicians manage adult or pediatric CRS. The focus of this study is intended to develop testing methods to improve the objectivity and specificity of diagnosis and allow for individualized therapy with less invasive, customized treatments instead of the traditional, empiric based, and radically exenterative therapies commonly employed in clinical practice. Specifically, it is now known that many patients with CRS have a greater concentration of non-typeable Haemophilus influenzae (NTHI) in the bacterial biofilms located within their sinus cavities compared to healthy patients. The specific hypothesis behind the proposed research is that the presence of NTHI biofilms, which are known to be highly recalcitrant, are positively correlated with the development of CRS and that unique lipooligosaccharides and inflammatory byproducts obtained from nasopharyngeal lavage fluids and/or swabs of sinus secretions may be used as a non-invasive biomarker for CRS. As a result, patients with symptoms of CRS specifically associated with NTHI biofilms could possibly obtain a non-invasive test in the physician's office that would allow the clinician to make a more accurate diagnosis and objectively follow each patient's responsiveness to customized therapy.
| Condition |
|---|
|
Chronic Sinusitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Improving Patient Care Via Proteomics Based, Microbe-Specific Detection of Chronic Rhinosinusitis |
whole blood nasal secretions nasal mucosa nasal polyps
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Chronic Rhinosinusitis
Patients with chronic rhinosinusitis as defined by American Academy of Otolaryngology-Head and Neck Surgery and American Rhinologic Society guidelines
|
|
Control Group
Patients undergoing endoscopic sinus surgery for diseases other than chronic rhinosinusitis (i.e., access to pituitary gland, etc)
|
Detailed Description:
Specific Aims:
Specific Aim 1 will test the hypothesis that a high throughput proteomics-based assay of nasopharyngeal lavage fluids and/or swabs of human sinus drainage material will be able to identify, with a high degree of sensitivity and specificity, patients with CRS specifically due to the presence of NTHI biofilms.
Specific Aim 2 will test the hypothesis that a priori assay for increased presence of phosphorylcholine-rich lipooligosaccharides in nasopharyngeal lavage fluids from chinchillas co-infected with adenovirus and biofilm forming NTHI will successfully predict, with a high degree of sensitivity and specificity, the development of CRS in this in vivo model.
Results from this project may: enable the design and conduct of a clinical trial to preoperatively identify patients with CRS earlier in their disease course (possibly prior to the initiation of long courses of empiric antibiotic therapy); aid in the development of non-surgical therapies to eradicate bacterial biofilms with the sinus cavities; result in the identification of an objective biomarker to monitor success with therapies; and ultimately lead to less morbidity and risk for complications compared to conventional surgical therapy. In addition, transforming this paradigm would make progress towards achieving the goals of the U.S. Department Health and Human Services Healthy People 2010 objective 14-19, which is "reducing the number of courses of antibiotics prescribed for the sole diagnosis of the common cold."
Eligibility| Ages Eligible for Study: | 5 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients from age 5 to 90 undergoing endoscopic sinus surgery for treatment of chronic rhinosinusitis
Inclusion Criteria:
- Clinical diagnosis of chronic sinusitis
- Undergoing surgery for treatment of their disease
Exclusion Criteria:
- None
Contacts and Locations| Contact: Subinoy Das, MD | (614) 293-8310 | subinoy.das@osumc.edu |
| Contact: Melanie Clark | (614) 293-8310 | melanie.clark@osumc.edu |
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Subinoy Das, MD 614-293-8310 subinoy.das@osumc.edu | |
| Contact: Melanie Clark (614) 293-8310 melanie.clark@osumc.edu | |
| Principal Investigator: Subinoy Das, MD | |
| Principal Investigator: | Subinoy Das, MD | Ohio State University |
More Information
Additional Information:
Publications:
| Responsible Party: | Subinoy Das, Assistant Professor, Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00962689 History of Changes |
| Other Study ID Numbers: | 2009H0067, KL2RR025754 |
| Study First Received: | August 19, 2009 |
| Last Updated: | November 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
chronic rhinosinusitis biofilm sinus tissue nasal secretions |
proteomics diagnosis decreased antibiotics Develop a test to identify patients with sinusitis subtypes |
Additional relevant MeSH terms:
|
Sinusitis Chronic Disease Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013